药品注册审批历史信息 |
申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 |
019537 | 086 | AP | 2016/07/26 | Labeling Revision |
019537 | 085 | AP | 2016/09/14 | Labeling Revision |
019537 | 084 | AP | 2014/11/21 | Manufacturing Change or Addition |
019537 | 083 | AP | 2015/02/02 | New or Modified Indication |
019537 | 082 | AP | 2013/08/14 | Labeling Revision |
019537 | 081 | AP | 2013/01/30 | Labeling Revision |
019537 | 080 | AP | 2011/10/18 | Labeling Revision |
019537 | 079 | AP | 2011/08/03 | Labeling Revision |
019537 | 078 | AP | 2011/06/10 | Labeling Revision |
019537 | 075 | AP | 2011/02/25 | Labeling Revision |
019537 | 074 | AP | 2011/11/15 | Labeling Revision |
019537 | 073 | AP | 2009/04/06 | Labeling Revision |
019537 | 071 | AP | 2009/06/24 | Labeling Revision |
019537 | 070 | AP | 2009/04/27 | Labeling Revision |
019537 | 069 | AP | 2009/02/13 | Labeling Revision |
019537 | 068 | AP | 2008/10/03 | Labeling Revision |
019537 | 067 | AP | 2008/01/18 | Labeling Revision |
019537 | 065 | AP | 2007/06/25 | Labeling Revision |
019537 | 062 | AP | 2006/06/19 | Labeling Revision |
019537 | 060 | AP | 2005/11/09 | Labeling Revision |
019537 | 057 | AP | 2005/05/18 | Labeling Revision |
019537 | 054 | AP | 2004/07/14 | Labeling Revision |
019537 | 053 | AP | 2004/07/14 | Labeling Revision |
019537 | 052 | AP | 2005/01/07 | Accelerated Approval |
019537 | 051 | AP | 2004/03/15 | Labeling Revision |
019537 | 050 | AP | 2004/03/15 | Labeling Revision |
019537 | 049 | AP | 2004/03/25 | Patient Population Altered |
019537 | 048 | AP | 2004/03/15 | Labeling Revision |
019537 | 045 | AP | 2002/12/10 | Manufacturing Change or Addition |
019537 | 044 | AP | 2002/08/02 | Expiration Date Change |
019537 | 043 | AP | 2002/12/13 | Package Change |
019537 | 042 | AP | 2001/12/04 | Manufacturing Change or Addition |
019537 | 041 | AP | 2002/04/17 | Labeling Revision |
019537 | 040 | AP | 2000/06/28 | Labeling Revision |
019537 | 039 | AP | 2000/06/28 | Labeling Revision |
019537 | 038 | AP | 2000/08/30 | New or Modified Indication |
019537 | 036 | AP | 2000/06/28 | Labeling Revision |
019537 | 035 | AP | 1999/06/09 | Control Supplement |
019537 | 034 | AP | 2000/06/28 | Labeling Revision |
019537 | 033 | AP | 1998/09/17 | Labeling Revision |
019537 | 032 | AP | 1998/11/18 | Package Change |
019537 | 031 | AP | 1998/09/17 | Labeling Revision |
019537 | 030 | AP | 1998/09/17 | Labeling Revision |
019537 | 029 | AP | 1997/06/03 | New or Modified Indication |
019537 | 028 | AP | 1996/11/22 | Labeling Revision |
019537 | 027 | AP | 1998/04/03 | Patient Population Altered |
019537 | 026 | AP | 1996/04/08 | New or Modified Indication |
019537 | 025 | AP | 1997/09/26 | Labeling Revision |
019537 | 022 | AP | 1996/10/10 | New or Modified Indication |
019537 | 021 | AP | 1996/09/11 | New or Modified Indication |
019537 | 020 | AP | 1994/03/14 | Control Supplement |
019537 | 019 | AP | 1995/09/13 | New or Modified Indication |
019537 | 018 | AP | 2011/10/18 | Labeling Revision |
019537 | 017 | AP | 1992/09/10 | Control Supplement |
019537 | 016 | AP | 1997/05/15 | New or Modified Indication |
019537 | 015 | AP | 1994/07/21 | New or Modified Indication |
019537 | 013 | AP | 1994/07/21 | New or Modified Indication |
019537 | 009 | AP | 1991/11/19 | Manufacturing Change or Addition |
019537 | 008 | AP | 1993/01/22 | Labeling Revision |
019537 | 007 | AP | 1989/10/25 | Control Supplement |
019537 | 005 | AP | 1988/11/01 | Control Supplement |
019537 | 004 | AP | 1988/10/12 | Control Supplement |
019537 | 002 | AP | 1988/02/24 | Control Supplement |
019537 | 001 | AP | 1988/02/24 | Expiration Date Change |
019537 | 000 | AP | 1987/10/22 | Approval |